The Recall Desk
HighFDA (Devices)·Z-1201-2023·Announced 2023-03-08

Medical Device Middleware: MYLA Software Fails to Apply AST Filter Rules

Biomerieux MYLA laboratory middleware may fail to apply activated antibiotic susceptibility test (AST) filter rules when sending results to clinicians. The defect affects VITEK MS users with versions 4.8.x and 4.9.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: This FDA Class II recall involves a software defect that prevents proper filtering of antibiotic-susceptibility results. No illnesses or injuries have been reported, but the potential for incorrect antibiotic recommendations based on incomplete test data constitutes significant risk of harm, meeting the High (3) severity category.

Plain-English summary

Biomerieux Inc is recalling MYLA laboratory middleware that connects VITEK MS microbiology analyzers to hospital information systems. The software has a defect that prevents antibiotic-susceptibility test (AST) filter rules from being applied to test results before they reach clinicians.

Antibiotic-susceptibility testing identifies which antibiotics are effective against bacterial infections and helps prevent inappropriate antibiotic use. When filter rules are not applied, clinicians receive incomplete test data that could affect patient treatment decisions.

The recall affects 19 MYLA systems located in Alabama, California, North Carolina, and Puerto Rico. The defect impacts systems running MYLA versions 4.8.X and 4.9.

Laboratories using affected systems should contact Biomerieux Inc immediately to obtain necessary software updates ensuring that antibiotic-susceptibility filter rules are properly applied before results are reported to clinicians.

The recalled product

Product
MYLA comprises AST Filters in conjunction with VITEK MS; middleware which connects microbiology laboratory instruments for ID/AST and blood culture activities and the laboratory information system (LIS).
Manufacturer
Biomerieux Inc
Category
Medical Device — Laboratory Information System / Microbiology Analyzer Middleware
Hazard
  • unfiltered-ast-results
  • software-defect

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (1)

  • Versions 4.7 and 4.8

Distribution

Distributed nationwide across the United States.

Related recalls

Same category